ERA® 11° DO Small Post Attachment SS

GUDID 08415491044549

This part contains: 1 female, 2 black, 2 white, and 1 orange male. 1.3mm post diameter, 9mm long. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. This product consist of a stainless steel female with a titanium nitride coating and a choice of four different post angles – 0º (straight), 5º, 11º and 17º, and two post diameters – 1.3mm and 1.7mm, both 9mm long. Six color coded males to create a consistent level of retention (white, orange, blue, grey, yellow, red). An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491044549
• NIH Device Record Key: e80e861e-5a4a-4083-9f91-097b40ece2a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERA® 11° DO Small Post Attachment SS
• Version Model Number: 811430
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 401-871-3489
• Email: maria.rao@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08415491044549 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913348

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08415491044549]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-06-07

On-Brand Devices [ERA® 11° DO Small Post Attachment SS]

• 08415491044549: This part contains: 1 female, 2 black, 2 white, and 1 orange male. 1.3mm post diameter, 9mm long
• 00841549101953: This part contains: 1 female, 2 black, 2 white, and 1 orange male. 1.3mm post diameter, 9mm long